"They're not just going to say, 'I'm not going to treat you.'". Hey yall! If you've had a premature baby in the past, your doctor may prescribe progesterone shots during your current pregnancy to help prevent early labor. Cutting off all access to the drug, whether it is Makena or its compounded versions, would be "a big disaster," especially for women in disadvantaged communities who are at a higher risk of preterm birth, says Dr. George Saade, the director of maternal-fetal medicine and chief of obstetrics at the University of Texas Medical Branch at Galveston. You can suck it up if your more concerned with having a healthy baby. If you feel a message or content violates these standards and would like to request its removal please submit the following information and our moderating team will respond shortly. A driver was shot and killed by North Las Vegas Police in the early hours of Friday morning after he reached for a gun during a traffic stop. Been having contractions like crazy but still no baby hoping to have her soon. 17P has the hormone document.write(def_progesterone_T); I will definitely be talking to my OB at my next appointment at 30 weeks, but wanted to see if anyone had any advice! We were taken aback by the amount of financial scope and influence in our specialty, they wrote, adding that the facts are resoundingly persuasive that doctors should not prescribe Makena. Much of that money, he says, was reimbursement for consulting, travel and fees.). The corporate plan took years because FDA scientists and outside experts questioned whether the drug was effective and safe. The doctor told me I was far enough along to go ahead and stop the shots. Horsey, the mother in Baltimore, said that when she recently got pregnant again the doctor and staff at the clinic she visits told her she should start the Makena shots. Tomorrow I have an appointment and going to ask him to stop giving me the shots because I cant feel like This every single day..", "I had my first child at 28w 5d baby stayed in NICU for almost 3 months but perfectly healthy now and 4 years old! Covis, which took over sales of Makena when it purchased AMAG Pharmaceuticals late last year, declined to make executives available for interviews. Dont stop, Ive read most women go into labor the week after they stop. So fingers crossed ", "I had my son 3 months early and almost lost him and was on pills every 3 hours to stop preterm labor, lost a son at 20 weeks preg due to him being to small to make it when my water broke, sat in the hospital for 3 months taking those pills every 3 hours With one daughter and a constant in drip of magnesium to have her at almost term, then when my husband and I got pregnant again we were concerned, they mentioned the Makena injection but it would go in upper buttocks every 7 days ..I tried it in hopes it would work and sure enough I had her on my scheduled due date with out one complication or preterm labor symptoms , now pregnant with our last child, which I again did the Makena and am at 39 weeks without complications! Cohn said in an interview that her group decided to investigate the long-term effects of Makena because of its similarity to another synthetic hormone called diethylstilbestrol, or DES. The spokesperson also pointed out that the FDAs decision to recommend the drugs removal was not because of safety concerns but because of conflicting efficacy data. The company believes that both the 2003 study and the new trial confirmed the drug was safe, the spokesperson said. Ive never had pain in or around the injection area after the initial shot. The Times found similar contributions going back to 2015. Controversy Kicks Up Over A Drug Meant To Prevent Premature Birth, Scientists Search For Causes Of Preterm Birth And Better Ways To Test For Risk, Premature Birth Rates Rise Again, But A Few States Are Turning Things Around, about 38% of patients were taking compounded 17P instead of Makena, said it will continue to monitor the issue. Today I went in for my injection and they did not bring my shots from the other location to the one I was being seen at. I havent had any noticeable side effects as others mentioned, I sometimes get an itchy lump but it goes away in a few days. It might work for some women but not all.". Currently 34+4 weeks with my second. ", "I would 100% recommend the makena shot! A powerful doctors group has fought a proposed California law that would require physicians to tell patients if they took money from drug or medical device makers. After the meeting, the companys payments to Sibai increased sharply. Please help! That information answered some of the questions posed by the agencys team of scientists reviewing the drug, but it never was able to convince one member of that group. I stopped at 36 weeks per my doctor and gave birth an exact week later. But this way is horrible", "I work at an OB/GYN office and take care of all the Makena referrals!!! It took some fighting, but my insurance pays for it 100%. So at the earliest lo would come at 36 weeks (37 weeks is full term). the FDA really screwed up when they took Compounded 17OHP off the market!!!! One way AMAG kept in touch with doctors it considered opinion leaders was at the Society for Maternal-Fetal Medicine. It went into the pockets of thousands of American obstetricians. For specific medical advice, diagnoses, and treatment, consult your doctor. The big problem is the whole doggone system. Decades later, scientists found it could cause rare cancers in the mothers children. A letter sent to the Food and Drug Administration in May 2021 by the Preterm Birth Prevention Alliance an organization created with money from Covis. 1 weather alerts 1 closings/delays Watch Now She was early but no where near as early as our son was. In 2012, it sued the FDA in an unsuccessful attempt to stop compounding gaining some ground later that year when a meningitis outbreak caused by a different compounded drug drew federal scrutiny of specialty pharmacies. Then came questions. ", "After two pregnancies that ended in loss at 24 weeks, my doctor did a cerclage at 12 weeks and started me on Makena injection at 16 weeks. A spokeswoman for the FDA said that the presence of a report in the database does not mean the drug caused the adverse event.. I would like to add that Yesterday the hospital did a test on my cervix to see if I would go into labor in the next 2 weeks it came back negative. Group Leaders arent expected to spend any additional time in the community, and are not held to a set schedule. ", "I was 16 weeks when I started my makena generic shot 4 days later my water broke and I lost my baby and doctors have no clue to why my water broke so fast even after I took the shot. I get itchy lumps & bruises but the chance of giving birth early & risking life long complications based on being sad, crying all day is so pathetic. I'm pregnant with my final baby and have had a cerclage placed again and my makena shots just arrived today. ", "I had my daughter at 35 weeks so with this pregnancy it was suggested I start the shots at 16 weeks until 36 weeks. Another concern: There was only one clinical trial the 2003 study funded by the government that had shown the drug lowered the risk of preterm birth. think twice before sharing personal details, foster a friendly and supportive environment, remove fake accounts, spam and misinformation, delete posts that violate our community guidelines, reviewed by our medical review board and team of experts. Makena's lack of effectiveness has not reduced what Covis lists as the drug's price currently $803 per weekly shot, according to GoodRx, which tracks national prices set by drug. At 18 weeks, I was hospitalized for severe pain, but fetus was growing normal, 19 weeks spoke to ob about the side effects and she said she never heard of this complaint yet. Questions about the higher rate of stillbirths were raised by experts on an FDA committee that met on Oct. 29, 2019, to discuss the drug. When Cochrane, an international healthcare research group that doesnt accept money from companies, set out to determine how pregnant women could avoid preterm birth, Makena did not make its list. A White House official confirmed that the Domestic Policy Council and the Gender Policy Council had met with alliance members. All rights reserved. I declined makena injections this time around because my MFM at the time said it didn't prove to make a difference in preventing preterm labor. Find advice, support and good company (and some stuff just for fun). She reminded them of the side effects she had suffered from the shots in two earlier pregnancies and how, despite taking the drug, she had still delivered her babies too soon. Sales reached $387.2 million in 2017 before starting to decline. I was nervous at first but decided it was with the chance if I could avoid having a premature baby again. A recent large study unequivocally failed to demonstrate that Makena reduced the risk of preterm birth, agency scientists explained in a 2020 memo. for the Makena was not proven to reduce rates of preterm birth in its long term study. Patients from the United States made up just 23% of participants in the study. Sign up for the California Politics newsletter to get exclusive analysis from our reporters. Thats a troubling thing to find out.. The drugs written label lists both as possible complications. But, more recently, a larger trial of lower-risk, international patients a study conducted by the drug's manufacturer, after the FDA's request suggested that the medicine did not work. Google "FDA Advisory Board Votes to Recommend Withdrawing Progesterone Therapy for Preterm Birth" to find article", "I am 37 wks pregnant with my 4th child. call makena care connection and ask for the copay assistance. Makena (hydroxyprogesterone) is an AMAG Pharmaceuticals drug, which was approved by the FDA in 2011, for prevention of preterm birth in women who had a prior spontaneous preterm birth. Love Mackena! We comply with the HONcode standard for trustworthy health information. Covis repeatedly cited the two groups recommendations for prescribing Makena in documents it submitted to the FDA demanding the drug stay on the market. Multiple phone calls to Makena, Specialty Pharm, Patient's insurance, and the patient take place during this time along with MULTIPLE faxes and notes in the chart. Please stay on it the full length of time. The associations website lists AMAG as an industry partner. The company gave at least $200,000 to the association in 2018, enough to become a sponsor of its Presidents Cabinet. That study was flawed. I am now 36 weeks and due for my last shot so for me its worked and the experience hasnt been bad at all. The correspondence that Covis and the alliance separately sent to the FDA mirror each other in key ways. January 2016. Stephen Chasen, professor of clinical obstetrics and gynecology at Weill Cornell Medicine in New York, said he cares for many minority women at risk of preterm birth. Oh and mine are $11.70 for a months supply. He was perfectly healthy though, in the NICU for 3weeks, which was amazing compared to his sister who spent 4 months. Makena, pronounced mah-KEE-na, is a hormone medicine (progestin) prescribed to lower the risk of having another preterm baby in women who are pregnant with one baby, and who've unexpectedly delivered one baby too early (before 37 weeks) in the past.. Makena is an injection given every seven days by a healthcare provider: Relying only on the case study can be very dangerous, Gillen said, referring to the stories of individual patients. I havent had any contractions (besides the occasion BH that go away when I change position), or any other symptoms of labor. So thankful since I just had a previous lost late November.So Im wondering if Im the only one having side effects from my progesterone injection shot. Roughly 1 in 10 infants were born prematurely in the U.S. in 2018, according to the Centers for Disease Control and Prevention. Placement is key with getting it not to burn like heck. Reviews may be edited to correct grammar/spelling or to remove inappropriate language and content. I start them next week. The Food and Drug Administration has granted a hearing on the Center for Drug Evaluation and Research's proposal to withdraw approval of Makena (hydroxyprogesterone caproate injection, 250. Dont take no for an answer. My cervix has been long at every check. Its main goal is to keep your cervix from changing prematurely. Deborah Mann Lake, a university spokeswoman, said Sibai wasnt available to comment. Makena Progesterone Shots? Orchid Health tells would-be parents its test can identify embryos with the lowest likelihood of developing cancer, schizophrenia and other diseases. The pregnancy that I had the cerclage and injections lasted until almost 36 weeks before I ended up with preeclampsia. my water broke early Thursday morning, I delivered a beautiful baby girl that night, all medical interventions to help . The FDA says it already considered those previous trials and had not changed its finding that the drug was not effective. We provide materials that disclose funding and include links to our website at every meeting we attend, she said in a statement. Hopefully this helps someone like me that was curious on the pain of the shot itself. KV introduced the drug at a list price of more than $1,400 a dose, or nearly $30,000 for the 20-week course of injections needed during many pregnancies. It will not help anyone who has an incompetent cervix etc. Complicating matters is the possibility that even if the FDA decides to let Makena remain for sale, or permits pharmacies to create their own versions of the drug for use, insurers might well refuse to pay. The educational health content on What To Expect is reviewed by our medical review board and team of experts to be up-to-date and in line with the latest evidence-based medical information and accepted health guidelines, including the medically reviewed What to Expect books by Heidi Murkoff. I was on it from 20 weeks to 36..they say 12 days after you stop the shot you go into labor, that was true for me as well. Those guidelines did not disclose that AMAG has been among the associations top financial supporters. (to stop contractions). "Now it is clear it is not effective," she says. PPROM is different than preterm labor because its not actually labor that causes the rupture, thats why an OB may not say its needed if your previous preemie was due to pprom. Based largely on AMAG's findings, the FDA's expert panel recommended in October, in a 9-7 vote, that the FDA withdraw its approval of Makena. ", "My first pregnancy was with my daughter who was born at 25 weeks weighing at 1lb12oz with a brain bleed, MRSA, and yeast infection. Doctors have been treating pregnant women with the synthetic hormone known as 17-alpha hydroxyprogesterone caproate, or simply 17P, since the 1950s. What is this care connection??? If it's more than an inch or so off, it burns so bad! Among its founding principles is that consumers should demand safety and reliability from the goods and services they buy.. Started them 4 weeks ago and havent felt the same way ever since, I believe my doctor thinks Im being dramatic and doesnt listen to me . The company would then get an exclusive license to sell it and the ability to raise its price. 57% of reviewers reported a positive experience, while 22% reported a negative experience. Its almost like a pulsing pain that comes and goes every couple mins. Stillbirths have been a concern since at least 2003, when the government trial showed a small but increased risk in women taking Makena. AMAG sent patients to speak at the FDA committee meeting in 2019. I felt my opinion did not matter, she said. Covis dismisses the results of the recent study since it included more white European women than Black Americans. In 2017, a study of the drug's cost by researchers from Harvard University found no notable difference between the outcomes of women who took Makena and women who took compounded 17P even though the mean per-pregnancy cost of Makena was $10,711 more than 17P. A Group Leader is a What to Expect community member who has been selected by our staff to help maintain a positive, supportive tone within a group. I do not get the bumps, itchiness, burning, etc symptoms like lost people I have read. Available for Android and iOS devices. These work to reduce the risk of premature birth through a mechanism which is currently not yet fully understood. I had my first daughter at 34 weeks and runs in the family pre term later. Horsey said she told them she had decided not to get the injections with this pregnancy and they initially pushed back. My doctor is having me do it again with this pregnancy and of course I'd rather be on the safe side..baby first. Group Leaders arent expected to spend any additional time in the community, and are not held to a set schedule. Group Leaders communicate with staff moderators and escalate potential violations for review, but they dont moderate discussions. Compounding facilities can be difficult to find. In August the FDA granted Covis a hearing to again review the evidence on the drug. I definitely think the progesterone has helped with keeping him cooking as long as he has been. . Makena rating summary 6.9/10 average rating 133 ratings from 152 user reviews. The American College of Obstetricians and Gynecologists has said it will continue to monitor the issue but has not changed its guidance to doctors in the meantime. Yet, both of her babies were born prematurely and Horsey said she suffered from Makena side effects, including migraines and depression. I previously ppromed at 33.5. In recent years, the league has become more friendly with corporations. The Nemours Foundation. ", "The Makena new way the administer the auto injection is HORRIBLE. nifedipine, progesterone, terbutaline, Prometrium, Brethine. So a little background, about 9 years ago I was pregnant with my daughter. The Times found a rising number of death investigations across the country were complicated or upended after transplantable body parts were taken before a coroners autopsy. The company was also giving Sibais employer large financial grants. KHN is not affiliated with Kaiser Permanente. Also, the majority of participants in the NIH trial about 59% were black, while the vast majority in AMAG's trial about 89% were white. Poor maternal care, especially of Black, Native American and Latina mothers, has long been associated with preterm births. They had to lay me down and cool me off. And, despite the prescriptions, the rate of preterm births in the U.S. has continued to rise. LAS VEGAS, Nev. (FOX5) - A driver was shot and killed by an officer with the North Las Vegas Police Department early Friday morning after they say he reached for a gun during a traffic stop. She pointed out that obstetricians prescribing Makena are protected from bad outcomes because they can show they are following guidelines issued by their professional societies. Three years after the FDA approved Makena, yet another company acquired rights to the drug. The drug got the green light through the FDA's. But compounding of 17P continued until 2016, when the FDA approved a preservative-free version of Makena and, in doing so, handed AMAG Pharmaceuticals the exclusive right to make the drug, ending the compounding of 17P. The uterus contracts during labor to help "push" a baby out of the womb for delivery. Just found out I reached my max copay assistance with Makena and have to pay full price after what insurance didn't cover (which insurance only covered $15). They dont yet know what harm the drug could cause over the years for mothers and their children. So I want to see what would happen if I stopped taking the injections at 24 weeks pregnant?! Ive been paying 400 bucks a month for the past two pregnancies!!! On October 5, 2020, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) proposed withdrawal of approval of Makena (hydroxyprogesterone caproate injection . Horsey ultimately convinced them she did not need Makena. I am opting out of my last two shots. In 2014, the manufacturer went bankrupt and sold Makena to AMAG Pharmaceuticals, which owns the drug today. Yes the shot in the butt hurts and you stay sore about 4 days. This educational content is not medical or diagnostic advice. They recommended it be taken off the market. This company is so SLOW!! In Makenas case, the agency said it would allow the drug to be sold while the company performed another clinical trial to show it actually saved infants from death or disability. But he pointed out that by far the majority of the patient volunteers in the large trial that prompted the FDAs push to remove the drug went on to have a delivery at full term whether they took the drug or the placebo. Two months later, alliance members met with the White House Domestic Policy Council, where they left encouraged by the councils receptivity, according to a note about the meeting on the alliances website. Now I am currently stoping Makena last week. She is a healthy happy 8 yr old now (I thank God everyday) My son was born at 32wks weighing 3lb 15oz. Two percent of volunteers taking the drug had a stillbirth compared with 1% of those taking the placebo. Sibai had been one of the researchers in the 2003 study of the drug and during the meeting he was called on repeatedly to answer questions. Create an account or log in to participate. Makena isnt supposed to be effective at stopping PPROM, just your cervical length changing, so Ive been wondering. It didnt work, said Horsey, 24. Instead, Covis Pharma, a Luxembourg company owned by private equity firm Apollo Global Management Inc., has continued to promote Makena, emphasizing a need by Black women, who are most at risk of preterm births. Your treatment will generally start between 16 weeks and 20 weeks of gestation. Well, I was on them and they checked my cervix at 28 weeks and it was long. It triggers the final maturation of your eggs 35 hours before the retrieval procedure. The accelerated process is aimed at helping patients at risk of serious health problems who dont yet have treatments. Last year, the agency stirred controversy when it used the rules to approve the drug Aduhelm for Alzheimers disease despite a lack of data showing that it slowed dementia. AMAG also gave money to the American College of Obstetricians and Gynecologists, the nations largest professional association for doctors caring for pregnant women and their children. This educational content is not medical or diagnostic advice. Under a red letterhead logo depicting a mother and child, the Preterm Birth Prevention Alliance asked to meet with Janet Woodcock, the acting FDA commissioner, to share their members concerns about the plan to halt sales of Makena. This is the longest I've ever been pregnant and I believe Makena is to thank for that. For more than a decade, a pharmaceutical company has said it holds the key to helping those infants: a drug called Makena, which is aimed at preventing premature birth. I wasnt offered care connection. But it was totally worth it. Makena is used to lower the risk of premature birth in a woman who has already had one premature baby. ", "Thinking about stopping Makena shots. Send her tips securely on Signal at (213) 327-8634. I was on Makena for my second baby after my water broke too early with the first. Please specify a reason for deleting this reply from the community. I have heard from others the injection are very expensive but they have ways to help lower your payments. "It's not like, Oh, they're going to be fine," he says. In a written statement, it pointed to a recent reanalysis of previous Makena trials that found evidence that the drug worked. It wants the FDA to allow it to keep selling the drug while it performs additional studies aimed at trying again to show that Makena helps patients or certain subgroups like Black women. It cost my husband and I 200 out of pocket for 10 shots ( 400 dollars total). My first was born early due to PPROM. Ive never been this far along and I am miserable hope baby comes soon but set to be induced in two weeks. The company said it saw a billion-dollar opportunity.. Durdin said she had heard similar stories from Black women who felt their doctors didnt listen when they raised concerns. It's to the point where our office needs to hire someone to just do this all day. Before it was acquired by Covis, AMAG had paid to be a member of the council since at least 2017, according to the leagues website. It was extremely painful in my arm and the pain doesn't subside til after about 10 mins and even after that you still feel soreness. What is Makena? this year I have been on makena since 17 weeks I'm now 37 weeks with no shots left I've made it :-) I was worried at first but have nothing negative to say and if your doctor recommends this for you I say do it and don't forget prayers ..", "I started the Makena auto injector at 18 weeks. Those professional groups should be working to change the system, Durdin said, so people can have better care and more time with their practitioners., There is absolutely no accountability, Durdin said. Covis gave the money to create the Preterm Birth Prevention Alliance to a well-known consumer group in Washington, D.C., called the National Consumers League. "I had my baby at 34 weeks and 6 days. But the Baltimore mother still suffered from the side effects. In 2019, more than 14% of births to Black women were preterm, compared with just over 9% of births to white women. Group Black's collective includes Essence, The Shade Room and Naturally Curly. Another option is the daily suppositories- I am on them and my MFM says they work just as well as the shots (sometimes better depending on your condition in my case). I'm 30 weeks with my 2nd pregnancy & have no complications. Makena is a form of progestin, a manmade form of a female hormone called progesterone. My doctor did know a drugstore that made their on progesterone injections. In South Los Angeles, Kimberly Durdin, a Black midwife at Kindred Space LA, said a visit for pregnancy care in the mainstream medical system may last just five minutes. TRIGGER SHOT: All of your shots are important, but the trigger shot is THE most important shot that you will take. Stopping Makena Shots early Currently 34+4 weeks with my second. The mothers had agreed to participate in the Child Health and Development Studies, a group who received prenatal care between 1959 and 1966 at Kaiser Permanente in Northern California. "And especially in big systems, you are discouraged from using non-FDA-approved medicines when there is an FDA-approved medicine available. Use of this site is subject to our terms of use and privacy policy. Ive been doing the Makena shots since 16 weeks, and my cervix has remained long and strong with no change. Doctors are torn between two clinical studies of the drug that had differing results: An older trial of American patients at high-risk of having a pre-term delivery showed Makena's active ingredient seemed to be effective. The story of Makena shows how pharmaceutical companies can use Americas drug approval system to make hundreds of millions of dollars from a cheap, decades-old medicine with questionable effectiveness and safety. Brittany Horsey of Baltimore was prescribed the drug Makena during two of her pregnancies because doctors believed she was at risk of giving birth too soon. Daniel Gillen, professor and chair of statistics at UC Irvine, sat on the 2019 committee. Executives at Adeza Biomedical in Sunnyvale, Calif., saw a financial opportunity when a government-funded study in 2003 found that the drug appeared to reduce the risk of preterm birth. I miss my baby boy I lost him May 14 2019. The drug Makena is widely prescribed to women at high risk of going into labor early, though the latest research suggests the medicine doesn't work. It's awesome! Reviews that appear to be created by parties with a vested interest are not published. Where did you hear that its not effective for PPROM? Kaiser Health News is a nonprofit, editorially independent program of the Kaiser Family Foundation. The panel voted 19 to 2 that the trial had failed to show that the drug reduced deaths or serious health problems in infants. Companies often hire these doctors to write medical journal articles or give speeches to other doctors about their products. You need to contact your doctor, Makena, insurance company, and pharmacy until someone makes them affordable.